1. Field
The present application relates to medical devices and methods for the detection of the Streptococcus bacteria.
2. Description of Related Art
According to the CDC, there are several million cases of Group A-hemolytic streptococcus bacterial infection (Strep A) reported each year. The strep bacteria is transmitted through the air and is highly contagious. Children who contract strep throat can develop PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders), a disorder associated with streptococcal infections. One of the symptoms of PANDAS is OCD (Obsessive Compulsive Disorder). For years medical experts thought the link between a strep throat and OCD was only coincidental, but now many believe PANDAS affects the part of the brain that controls movement and behavior. CDC guidelines for medical doctors state that a strep test should be performed if a patient presents with two of the four symptoms, namely: white matter on tonsils; fever; painful swollen glands; and a lack of coughing. Group A Streptococcus is one of the most significant human pathogens causing acute pharyngitis, tonsillitis impetigo, and scarlet fever. It is very important to differentiate streptococcal infection from other etiologic agents so that appropriate therapy may be initiated. Rapid diagnosis and timely treatment of Group A Streptococcal pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis.
The accurate diagnosis of Strep A in children is largely dependent on the cooperation of the child and the medical practitioner's ability to collect a good specimen. The current device for collecting a sample is a sterile swab comprised of polyester and rayon. The tip rests at the end of a wooden stick which measures six inches in length. The method of specimen collection involves the use of two sterile swabs held together and simultaneously inserted into a child's mouth. In children over the age of 6, the child's head is tipped slightly backward so that the practitioner can visualize the tonsils. The tonsils are then swabbed with the sterile swabs. This sensation for many children is uncomfortable and engages the gag reflex. For children undergoing the conventional swab method, it often feels as if the swabs are being jammed or forced down their throat. In children ages 2-5, the practitioner must hold the child's jaw firmly with one hand while trying to swab the throat with the other. Parents are often asked to assist in mildly restraining their children so that the swabs may be inserted far enough into the mouth in order to reach the back of the throat to collect the specimen. This method is unpleasant for the child and awkward to administer for the practitioner. However, this is the only test on the market for the diagnosis of Strep A bacteria. One swab is used for the rapid test, performed on site in the practitioner's office or on-site laboratory, and the other swab is sent to an off-site lab to be cultured. With a rapid strep test, results are ready in 10 minutes instead of 1 to 2 days with a throat culture. The rapid test utilizes a chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen. Test strips or devices are treated with specific Strep A antibodies which react with the Strep A antigen if the bacteria is present. If the rapid strep test results are positive, antibiotics may be started immediately. The rapid strep test can give false-negative results even when strep bacteria are present. For these reasons, a throat culture is more accurate than the rapid strep test. Regardless, the accuracy of these tests is totally dependent on the collection of a good sample from the mucosa located in the back of the throat where the Strep A bacteria cultivates. The present application advances the current method and eliminates the problem of unpleasantness for a child and awkwardness for the medical practitioner while ensuring a sufficient sample is obtained.